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A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112290
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : January 14, 2022
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jeffrey B. Geske, Mayo Clinic

Brief Summary:
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.

Condition or disease
Hypertrophic Cardiomyopathy

Detailed Description:
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025





Primary Outcome Measures :
  1. Atrial fibrillation incidence in hypertrophic cardiomyopathy [ Time Frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring. ]
    Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea

  2. Atrial fibrillation recurrence in hypertrophic cardiomyopathy [ Time Frame: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring. ]
    Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea

  3. Ventricular arrhythmia incidence in hypertrophic cardiomyopathy [ Time Frame: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring. ]
    Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with hypertrophic cardiomyopathy who are participating in (or previously participated in) Mayo Clinic study 17-003514 and/or 16-009474
Criteria

Inclusion Criteria:

  • Currently or previously enrolled in 17-003514 and 16-009474
  • Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy
  • Both sexes
  • Able to consent

Exclusion Criteria:

  • Vulnerable study population
  • Known atrial fibrillation
  • Pacemaker/ICD implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112290


Contacts
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Contact: Nicholas Wozniak 507-255-8794 Wozniak.Nicholas@mayo.edu
Contact: Shahid Karim, MB, ChB 507-422-0763 Karim.Shahid@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jasmine Sexton, CCRP    507-538-7178    Sexton.Jasmine@mayo.edu   
Contact: Jeremy B Smith       Smith.Jeremy@mayo.edu   
Principal Investigator: Jeffrey Geske, M.D.         
Sub-Investigator: Virend Somers, M.D., Ph.D.         
Sub-Investigator: Choudhary Anwar Chahal, Ph.D.         
Sub-Investigator: Konstantinos Siontis, M.D.         
Sub-Investigator: Shahid Karim, M.B., Ch.B.         
Sub-Investigator: Shreyas Venkataraman, M.B.B.S.         
Sub-Investigator: Meghna Mansukhani, M.D.         
Sub-Investigator: Peter Noseworthy, M.D.         
Sub-Investigator: Jan Bukartyk, M.S.         
Sub-Investigator: Sean Caples, D.O., M.S.         
Sub-Investigator: Yong-Mei Cha, M.D.         
Sub-Investigator: Thomas Foley, M.D.         
Sub-Investigator: Paul Friedman, M.D.         
Sub-Investigator: Bernard Gersh, M.B., Ch.B.         
Sub-Investigator: Amar Killu, M.B.B.S.         
Sub-Investigator: Grace Lin, M.D.         
Sub-Investigator: Rick Nishimura, M.D.         
Sub-Investigator: Thomas Olson, Ph.D., M.S.         
Sub-Investigator: Steve Ommen, M.D.         
Sub-Investigator: Aiswarya Rajendran, M.B.B.S.         
Sub-Investigator: Robert Rea, M.D.         
Sub-Investigator: Phillip Schulte, Ph.D.         
Sub-Investigator: Erik St Louis, M.D.         
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
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Principal Investigator: Jeffrey Geske, MD Mayo Clinic
Additional Information:
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Responsible Party: Jeffrey B. Geske, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04112290    
Other Study ID Numbers: 17-011376
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey B. Geske, Mayo Clinic:
Atrial fibrillation
Ventricular tachycardia
Arrhythmia
Hypertrophic cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases